Diode Laser Therapy Systems: E-Beauty Machine

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E-Beauty Machine

E-011 Diode Laser Therapy Systems

E-011

Diode Laser Therapy Systems

User Manual

PubDate: Feb.04,2016

Exec.Date: Feb.04,2015

E-Beauty Machine

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E-011 Diode Laser Therapy Systems

Contents

1. Overview ...................................................................................................................................................5

1.1 Copyright.........................................................................................................................................5

2. Storage and Transportation Requirements..........................................................................................6

3. Requirements to Equipment Installer and Workshop .........................................................................6

3.1 Requirements to Equipment Installer .........................................................................................6

3.2 Unpacking and Inspection ............................................................................................................6

3.3 Warning Signs ................................................................................................................................6

3.3.1 Entrance Sign .....................................................................................................................6

3.3.2 Laser Irradiation through the window ..............................................................................7

3.3.3 Prevention of Laser Reflection .........................................................................................7

3.3.4 Laser Safety Mark ..............................................................................................................7

4. Safety Protection and Technology Guarantee ....................................................................................7

4.1 Brief Introduction............................................................................................................................7

4.2 Eye Protection ................................................................................................................................7

4.3 Electrical Protection.......................................................................................................................8

4.4 Fire Hazards ...................................................................................................................................8

4.5 Protection from Risk of Laser Beam Scattering ........................................................................9

4.6 Setting of Safety Warning.............................................................................................................9

4.7 Safety Label and Position.............................................................................................................9

5. Technological Theory and Scope of Application ...............................................................................15

5.1 Technological Theory..................................................................................................................16

5.2 Scope of Application ...................................................................................................................16

5.3 Contraindications .........................................................................................................................16

6. Product Descriptions .............................................................................................................................17

6.1 Brief Introduction..........................................................................................................................17

6.2 The Main Console (picture) ........................................................................................................18

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6.2.1 Touch Screen....................................................................................................................18

6.2.2 Key Switch .........................................................................................................................19

6.2.3 Emergency Switch ...........................................................................................................19

6.2.4 Hand piece Connector .....................................................................................................19

6.3 Hand piece....................................................................................................................................20

6.3.1 Indicator Light of Laser Output .......................................................................................20

6.3.2 Laser Aperture ..................................................................................................................21

7. Technical Parameters and Relevant Requirements .........................................................................21

7.1 Technical Parameters .................................................................................................................21

7.2 Relevant Requirements ..............................................................................................................22

8. Equipment Installation ...........................................................................................................................22

8.1 Standard Accessories .................................................................................................................22

8.2 Installation.....................................................................................................................................23

8.2.1 Installation Environment Requirements ........................................................................23

8.2.2 Installation Procedures ....................................................................................................24

8.2.3 Water Injection ..................................................................................................................24

9. Operation Instruction .............................................................................................................................25

9.1 Preparations .................................................................................................................................25

9.2 System Start-up ...........................................................................................................................25

9.3 Skin Test .......................................................................................................................................25

9.4 Treatment Process ......................................................................................................................27

9.4.1 Welcome Interface ...........................................................................................................27

9.4.2 Self-test Interface .............................................................................................................28

9.4.3 Working Interface .............................................................................................................29

9.4.4 Set-up Interface ................................................................................................................32

9.4.5 Warning Alarm Interface..................................................................................................37

9.4.6 Error Interface ...................................................................................................................38

9.5 Equipment Turn Off .....................................................................................................................39


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10. Maintenance and Repair ....................................................................................................................39

10.1 Equipment Maintenance...........................................................................................................39

10.2 Clean of Treatment Head .........................................................................................................39

10.3 Equipment Repair......................................................................................................................39

10.4 Usable Life, Periodical Inspection and Disposal Requirements of Equipment ................40

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1. Overview
Thank you for choosing E-011 Diode Laser Therapy Systems produced by E-Beauty Machine.

E-011 Diode Laser Therapy Systems is produced according to the latest trend of the global
epilation market. With a long pulse width and typical 808 nm wavelength, this laser hair removal
system penetrates epidermis to reach hair follicles. Based on the selective photo-thermal theory,
laser energy is preferentially absorbed by melanin in hair, damaging the hair follicle which the loses
nutrition losing its ability to regenerate, which can very on hair growth stage At the same time, the
unique sapphire contact cooling technology in the hand piece cools down the epidermis to prevent
a burning sensation. Therefore, E-011 Diode Laser Therapy System can be a less painful
treatment and have permanent hair removal after 8-10 sessions.

This device adopts a continuous pulse output mode. Once appropriate parameters are set,
treatment can begin by sweeping over the area to be treated. During the treatment process, the
laser with 808 nm wavelength penetrates epidermis and reaches corneum layer and be absorbed
by the melanin down to the hair follicle and surrounding tissues which is then turned from energy
into heat. If hair is at desired hair growth follicle is then damaged and ceases to grow.

An Effective and quick slide treatment based on consecutive pulse output makes laser hair
removal more safe, convenient and quicker.

As the Class 4 laser products, E-011 Diode Laser Therapy Systems produces laser beam with a
high power density. Please be very careful when using Diode Laser. This equipment must be
operated by a professional to avoid danger or injury. Please read this operating manual carefully
before using it. Please contact with Beijing E-Beauty Machine if you have any questions about
safety and operation.

Warning

No modification of this equipment is allowed!

Please unplug the power if there is urgent condition in need of outage.

1.1 Copyright

The E-011 Diode Laser Therapy Systems is one of many important intellectual properties
belonging to E-Beauty Machine. Its design, hardware and software are all patented. Counterfeiting
is strictly prohibited.

Beijing E-Beauty Machine reserves copyright to this User Manual. Its reproduction in parts or
entirety can only be approved by E-Beauty Machine. The manual will be updated along with

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product update at our discretion.

2. Storage and Transportation Requirements

This product can only be placed in the original package for transportation and storage
recommended to avoid injury and damage.

This product should be stored in a well-ventilated and dry environment with the temperature of
20℃—55℃ and relative humidity of 10%—93%. Pollution from acid, alkali as well as corrosive
products should be avoided as well. Direct exposing to sunlight and sharp shaking during the
transportation are forbidden.

Please use its original package if second transportation is needed.

3. Requirements to Equipment Installer and Workshop

3.1 Requirements to Equipment Installer

The work of unpacking and installation of the product should be completed by engineers from
Beijing E-Beauty Machine or other appointed service agents, who will also be responsible for spot
test and acceptance check.

3.2 Unpacking and Inspection

All our products are carefully packed prior to delivery, please ensure you check packing list to
ensure there is no accessories missing or damage to equipment. We recommend keeping all
packing materials in case of sending device back for repair if needed or for storage purposes.

Please feel free to contact us or our authorized representatives for further questions.

3.3 Warning Signs

Each operating room should display a warning sign. Its entrance should display an additional
warning sign stating “Class 4 Laser Product at work”.

3.3.1 Entrance Sign

Each laser operating room should have warning signs clearly displayed.

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 Each operating room should be prepared with laser safety warning sign with clearly stated;

 The laser warning light should be placed on each workshop entrance. When the laser device
is at work, the warning light should also be turning on to prevent others coming into the
operating room.

3.3.2 Laser Irradiation through the window

Laser beam radiation through window should be avoided when device is in use.

3.3.3 Prevention of Laser Reflection

Avoid any mirrors in treatment room; always check if there is any reflective equipment as well as
jewelry on client which could also reflect.

3.3.4 Laser Safety Mark

All entrances and exits of workshop as well as windows through which laser may leak radiation
should be marked with safety sign and present warning that laser is dangerous.

4. Safety Protection and Technology Guarantee

4.1 Brief Introduction

E-011 Diode Laser Therapy System is precise medical laser equipment, which is developed for
medical professionals. The systems of this Device have gone through strict safety test and
standard operation will not bring about malfunctions. Therefore, the safety of operating personnel
and patients from being injured by laser radiation, please carefully read this chapter and relevant
connections in other chapters. Besides, operating personnel of Laser Device should have taken
relevant training to operate device.

E-011 Diode Laser Hair Therapy Systems belongs to Class 4 Laser Product, which has high
energy, thus people should be very careful during process of operating the Device. Any
inflammable goods should not be close to laser beams!

4.2 Eye Protection

Warning
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Avoid looking at direct, reflected or scattered laser beams. Avoid direct observation of
laser beam from optical output or hand piece as it may damage retina.

NOHD-Nominal Ocular Hazard Distance

NOHD represents that irradiance or exposure dose are lower than the Maximum Permissible
Exposure (MPE) distances. The NOHD value of this Diode Laser Therapy System is 4.57 meters,
if it is not intended observation.

Safety goggles in the workshop should be marked with clear signs so as to guarantee all persons
including patients wear safety goggles for eye protection.

Safety goggles with relevant wavelength are equipped with device.

4.3 Electrical Protection

This Device quotes following electric safety standards:

EN60335-1:2012 Household and similar electrical appliances – Safety- Part1: General

requirements

EN55014-1: 2006+A2:2011 Electromagnetic compatibility —Requirements for house hold

appliances, electric tools and similar apparatus —Part 1: Emission

EN 55014-2:1997 Electromagnetic compatibility-Requirements for household appliances

Attention

To avoid risk of electric shock, this equipment must only be connected to a supply mains

with protective earth.

4.4 Fire Hazards

Danger

Laser Device and laser beams should be avoided near inflammable good, such as
anesthetics and other inflammable solvents. There should not be any papers or plastic
products in laser working areas, within distances, those materials will cause burning if
considerable energy is absorbed.

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If Equipment is not in use during the process of changing patients, machine mode should always
be set on standby.

4.5 Protection from Risk of Laser Beam Scattering

Avoid laser beams’ exposing on combustible materials, as it will cause burning.

Hand piece should be placed back on hand piece holder if there is no treatment.

In Treatment this device should only be operated by a medical professional, any other person is
prohibited to operate device.

Attention

Take away keys if the laser device is not in use.

Dangerous radiant exposure may be caused if the device is not controlled or adjusted in
accordance with this instruction.

4.6 Setting of Safety Warning

After your turn device on, it will first be set on standby, allowing no power through device. Only by
pressing on ready will allow device to perform service.

With complete optimization, E-011 Diode Laser Therapy System will release an alarm and pop out
warning interface if any link breaks down or run-time error appears. At the same time, the master
control program will emit a warning sound, part of laser system will turn into the state of shut down
and the hand piece could not control laser outlet, either.

Attention

When the fault code is shown in the case of product malfunction, please stop using

product and contact manufacturer or service agents as soon as possible.

4.7 Safety Label and Position

According to relevant standards and regulations, appropriate warning marks are pasted on
relevant positions, which are shown in the following picture.

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Label Position

Laser Warning Label

Emergency Shut-off Label

Class 4 Laser
Description

Switch Label

Attention Label

Illustrated Labels of Attention, Emergency Shut-off, Switch and their Positions

Maximum Water Level

Water Re-fill Label

Minimum Water Level

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Illustration of Maximum and Minimum Water Level

Label of Power Input and Fuse Protector

Label of Water Inlet

Label of Interlock Connector


Label of Vent

Label of Foot Switch Label of Drain

Illustration of Labels of Nameplate, Power Input and Fuse Protector, Remote Control Interlock
Connector, Foot Switch, Water Inlet, Vent, Drain etc. and their Positions.

Laser Aperture Label

Illustration of Labels of Laser Aperture and Its Position

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Serial
Description Label
Number

1 Laser
Warning

2 Attention

Class 4 Laser
3
Description

Emergency
4
Shut-off

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5 Key Switch

Maximum
6
Water Level

Minimum
7
Water Level

Water Re-fill
8
Label

Power Input
10 and Fuse
Protector

Interlock
11
Connector

12 Foot Switch

13 Water Inlet

14 Vent

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15 Drain

Laser
16
Aperture

Prohibit
17
Stacking

18 Keep Dry

Temperature
19
Limitation

Atmospheric
20 Pressure
Limitation

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Humidity
21
Limitation

22 Upward

Handle with
23
Care

Earth
24
Connection

Degree of
Protection
against
25
harmful
ingress of
water

5. Technological Theory and Scope of Application

Warning

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Only professional medical staff with specific trainings of laser products and clinical
applications can operate this Device.

5.1 Technological Theory

Laser Selective Photo thermal effect plays a decisive role in hair removal. As the fundamental
theory for Diode Laser’s hair removal function, Laser Selective Photo thermal makes the target
tissues (melanin in follicle and hemoglobin in hair papilla nutrient vessels) shows perfect
absorbency to specific wavelength. Treatment time for each pulse should be equal to or less than
target issues’ thermal relaxation time. Thus photo thermal effects will be limited in target issues,
and prevent thermal energy’s damage to surrounding tissues. At the meantime, hair follicles will be
effectively damaged and hair regeneration will be prevented. There is also no possibility for the
formation of scars. This kind of effect is featured with degeneration of hair follicles, depigmentation
of regenerated hair. While the hair follicles in the growing period have full pigmentation, it is easy
for them to absorb laser beams in a certain wavelength so as to achieve the therapeutic objective.
In consequence, Diode Laser Therapy System is safe and permanent for hair removal. With a
wavelength of 808 nm, Diode Laser Therapy System penetrates into the skin with a depth of
2.5mm. Its influences cover hair follicles in different positions with different depths. Scattered in
hair follicles stromal cells, melanin will be transferred to hair shaft during the process of hair growth.
Melanin is rich in hair follicle epithelium, hair papilla, and hair cortex. Melanin selectively absorbs
laser energy and the produced energy immediately forms local high temperature, which damages
hair follicles and hair shaft, hinders and terminates hair growth. Laser energy tends to be easily
absorbed by melanin in hair follicle and hemoglobin in dermal papilla nutrient vessels, and then
producing photo thermal effects. When the temperature in hair follicles rises to some certain
degree, thermal expansion happened in hair follicle fractures melanin cells and be pushed out of
hair pores by steams. At the same time, dermal papilla nutrient vessels are damaged because of
hemoglobin solidification. Under above dual functions, effective hair removal will be achieved.

5.2 Scope of Application

Intended for the treatment of leg veins, other lenign vascular lesions, hair removal, and permanent
hair reduction.

5.3 Contraindications

Patients with the following conditions are not allowed to proceed with treatment.

1) Patient had been treated with other ways (honey wax hair removal, electrolytic hair removal) in
6 weeks;

2) Patient with active infection lesions or open wounds in area of treatment;

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3) Patient having history of photosensitive disease or taking photo sensitizer Within the last 3
months;

4) People having a history of using 13-cis retinoic acid in 6 months;

5) Patients with cicatrix;

6) Patients who have had sun exposure within the last 4 weeks;

7) Patients in pregnancy or breast feeding;

8) Existing tattoos in treatment area;

9) Hypertension or severe heart condition patient;

10) Diabetes, AIDS, SLE or epileptic patients, or patients have taken treatments with
glucocorticoid.

11) Patients with mental disorder.

6. Product Descriptions

6.1 Brief Introduction

Major components of E-011 Diode Laser Therapy Systems:

——Main Console

——Treatment Hand piece

——Foot Switch

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6.2 The Main Console (picture)

1)10.4 inch touch screen 5)Treatment hand piece

6)Holder of
treatment
2)Emergency switch hand piece

10)Water Inlet
3)Key switch
7)Power cord inlet

8)Interlock connector
4) Connector of
9)Foot Switch
treatment hand
piece 11)Vent

12)Drain

Major components of the main console include:

1) 10.4 inch touch screen

2) Emergency switch

3) Key switch

4) Connector of treatment hand piece

5) Treatment hand piece

6) Holder of treatment hand piece

7) Power cord Inlet

8) Interlock connector

9) Foot Switch

10) Water Inlet

11) Vent

12) Drain

6.2.1 Touch Screen

Diode Laser Therapy System adopts 10.4 inch touch screen, which is the main interface for
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operation. All the parameters setting and system control and equipment status are to be realized
through this screen.

Sharp objects are not allowed to touch the surface of screen to avoid scratching.

All liquids are not allowed to splash the touch screen to avoid damage.

6.2.2 Key Switch

Key switch controls The ON and OFF system. When it is in the position of “O”, the system is in the
inactive state.

Two keys are randomly equipped with the Device. Only when the key switch is in the position of “O”,
the key can be pulled out. When the key switch is in the position of “|”, the system of the Device
will be launched and touch screen will display the main interface.

Keys for the switch should be kept and managed by manager or professional trainings.

Attention
Please take away keys from its switch if the equipment is not in use.

6.2.3 Emergency Switch

Emergency switch is used for laser output shut down in emergency. Before reset of the Device,
please turn the key switch to the position of “O” and then rotate emergency switch according to
arrow directions to the normal state. After that, turn the key switch to the position of “|”. The
system will be launched again.

6.2.4 Hand piece Connector

The connector is used for connecting the main console and hand piece.

In the form of slot, this connector closely links control system, cooling system in the main console
and corresponding lines in the hand piece. Therefore, the outlet control of laser stack in hand piece
and cooling control of Sapphire contact refrigeration.

Pay attention to the connector direction when linking the hand piece and main console. After
adjusting the docking position, press closely on the elastic buttons in bilateral sides of hand piece
connector and press inward in vertical direction to the main console, until the hand piece and slot
are successfully connected. When buckle in hand piece connector automatically pop-up, loosen
elastic button. Then the hand piece is successfully connected with the main console.

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Attention

Hand piece connector bears tight link between main console and diode laser stack’s circuit,
control and cooling systems. In order to guarantee perfect connection, it is not allowed to
pull out electrical plug. If necessary, please cut off the power of the main console, and
carry out the operation of installation or disassembling.

6.3 Hand piece

Warning

Treatment hand piece is commonly called a hand piece, which is the vital part and the main
applied part for laser output, its inner structure is very precise and complex, private
disassembly is forbidden.

6.3.1 Indicator Light of Laser Output

Indicator of Laser Output is in the upward side of the hand piece. It shows signal with yellow light or
red light.

When the Device is in a state of “standby”, the indicator light will not light up. After the parameters
are adjusted, the system will switch into the “prepare” state, the light turns to yellow, which
indicates systems are normally operating and can be used in the treatment. Press the button on
the hand piece, the indicator light turns red, as well as the laser output after two seconds.

As long as there is laser output, the Indicator light will light up. Indicator light and laser output are in
complete synchronization and indicates the laser output state.

When the indicator light is out, it means that the system is in emergency and abnormal output. At
this moment, the system will immediately stop the laser output, while relevant warning interface will
pop out on the touch screen to reveal the error status.

Attention

During the treatment process, if the indicator light is out, please loosen laser output button
on the hand piece immediately, at the same time switch the emergency shut-off, or conduct
other trouble shooting operations.

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6.3.2 Laser Aperture

Warning

In the working state 808 nm Diode Laser output through this aperture. Do not directly look
at aperture or focus it on inflammable goods or anything reflective.

Laser aperture is mainly composed of sapphire crystal. In the meantime of guarantee the laser
output, it will provide effective refrigeration for the epidermis and protect skin from injury.

In the process of operating, the laser aperture should be kept clean all the time, since dirt or hair
residue may affect laser output and bring injury to skin.

The laser aperture in hand piece is a component that is directly in touch with patient skin, thus
timely sterilizing before and after the operation of the Device is necessary.

7. Technical Parameters and Relevant Requirements

7.1 Technical Parameters

Laser source Diode stack

Laser wavelength 808 nm

Laser class Class 4

Electric Security Classification Type B ClassⅠ

Pulse width 5 ms-400 ms

Frequency 1 Hz-10 Hz

Laser aperture size 14 mm ×12 mm

Spot size 12 mm ×10 mm

Fluence 0-120 J/cm2

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Air cooling, water cooling


Cooling methods
and semi-conductor cooling

Input power 1300 VA

Power source 110-240 VAC, 50-60 Hz

Fuse protector T6.3A, 250 VAC

Dimensions (Length Width Height) 480 mm× 470 mm× 1045 mm

Net weight 40 Kg

7.2 Relevant Requirements

Working environment requirements:

Relative humidity: 30%-70%

Storage environment requirements:

Storage temperature in transportation: -20℃—+55℃

Relative humidity: 10%—93%

Atmospheric pressure: 500hPa—1060hPa

8. Equipment Installation

8.1 Standard Accessories

index Material code Accessories Quantity

1 1H03 Main Console 1

2 3H14 Treatment Hand piece 1

3 2DG0037 Key 2

4 3H16 Foot Switch 1

5 3H15 Interlock Plug 1

6 2AP0146 Fuse 2

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7 2K*0065 Protective Goggle 1

8 2DH0008 Eyeshade 1

9 2DH0131 Instruction Manual 1

10 2F*0002 Power Cord 1

11 2DH0009 Funnel 1

12 2DH0013 Warranty Card 1

13 2DH0014 Certificate of Inspection 1

14 2DF0116/2DF0117 CPC Sockets 1

15 2DF0064 Silicon Tube 1

16 2I*0069 Hex Wrench for M3 1

17 GM3*25Y3B M3x25 Hex socket head cap screws 5

18 GM5*20P1B M5X20 Cross recessed pan head screws 3


Holder of treatment hand piece Installation
19 2DH0200 1
Instructions

8.2 Installation

8.2.1 Installation Environment Requirements

Before dismantling external packing, it should be guaranteed that installation area, environment
and equipment power supply meet requirements put forward in this chapter.

During installation, the equipment should be away from thermal ventilation and keep safe distance
from other hazardous materials.

Before delivery, the input power is preinstalled in accordance with local nominal voltage or met with
customer’s demand.

The electrical requirements in the process of installation are in as followed:

 Power input: 110-240VAC 50-60Hz;

 The ground electrode in the power protection sheath should be connected with earth through
wall Line; a well earthed circuit is very crucial to safe operation;

 In order to guarantee the Device is operating in an appropriate state, indoor temperature


should be kept about 20℃, relative humidity should not be above 70%; Air-conditioner is
needed when necessary.

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8.2.2 Installation Procedures

 Unfold the outer packing and put the Device in the primarily settled position;

 Unpack the accessories bag, follow the instruction to fix the Holder of treatment hand piece on
the main console;

 Unpack the treatment hand piece packing and insert hand piece into the connector in the main
console;

 Connecting the interlock plug;

 Connecting the Footswitch;

 Connect the power cord;

 Insert the key into the switch and prepare to start the device.

Attention

It is necessary to assemble interlock switch properly for valid operation. There is a


interlock plug which has been shorted Pin 1 and Pin 2 in accessories bag can disable the
interlock detecting function.

8.2.3 Water Injection

Prepare 3 liters of distilled water or pure water. Please plug the funnel with CPC water nozzle into
the water inlet socket, which is located on the back of the equipment in an unpowered condition.
Add distilled water or pure water into the box and observe water level indicator on the side of
equipment. Make sure the water is not above the maximum water level. When the system begins
operation, please keep observing water level indicator. If the water level is lowered, it is suggested
to add more water, make sure the water is above the RE-FILL water level. Plug treatment hand
piece, connect power wire and start the equipment and keep the water way operating for 1 minute.
After the completing water injection, please unplug funnel with CPC water nozzle.

Attention: press down the aluminum flake of CPC water nozzle, then the funnel with CPC water
nozzle can be unplugged easily.

The water block shall be installed into vent when equipment is in transporting with water in-filled.
The water block can be unplugged by inward pressing.

It is advisable to change water once a month.

With the function of water flow testing, this equipment will continuously give an alarm if water in

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tank is insufficient or air is existing in water circulation. As a consequence, alarm releasing is a


normal phenomenon if water flow test fails because a little air in the waterway may not be
completely discharged for the first time of water adding or changing. All you need to do is to reset
the device for 3 to 5 times till all air entirely emitted from waterway. The alarm will then be relieved.

Warning

Water used in the Device should only be Distilled water or purified water. Tap water or
mineral water is forbidden.

9. Operation Instruction

9.1 Preparations

Before treatment, please confirm the following information:

1) Make sure that water level is in the stipulated level;

2) Examine whether all accessories have been connected;

3) Make sure that all people in treatment area are wearing protective goggles or eyeshade;

4) Make sure that the emergency switch is releasing.

9.2 System Start-up

After finishing preparatory work, turn the power inlet switch to the position of “—”. Then turn the key
switch clockwise to the position of “︱”. The system will start-up and the display screen will show
“Welcome”.

After System Start-up, the system will load into a self-testing process. If there is any error, it will
automatically release alarm and the error code will also be shown on the screen. Please take
“malfunctions diagnosis and analysis” for reference, or call us or our agents for help immediately.

9.3 Skin Test

Skin test is very important before treatment; relevant details are as followed:

1) Choose appropriate area for a test patch. If the target treatment area is the whole face, try to
choose a position that will not influence facial beauty, such as bottom of ear. If the target
treatment area is chest, neck or other parts of the body, then the area that will not affect visual

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appearance should be chosen for experimental test. Meanwhile, injured or infected skin should
not be treated.

2) Before skin test, the surface of skin should be cleaned. A thin layer about 2-3mm of conductive
gel should be spread in the skin test area. Take out laser treatment head and closely touch skin
vertically with appropriate pressure slide in the direction of hair growth for 2 to 3 times. Wait for
5 to 10 minutes and then remove the gel, observe the test effect.

 If there appears erythema or edema around hair follicle without epidermis reactions, it
achieves a perfect effect. The following treatment could be set with the same energy and
pulse type.

 If there is not any visible change on the skin, skin test should be continued with 1-2J/cm2
energy increased.

 If the patient feels severe pain or there appears blister in the skin test area, it is probably
because the energy is too high or too much repetitive treatment is given. Then the energy
should be lowered if the treatment continues.

Attention

1) Patients and operators should wear protective goggles during the process of
treatment and patient should take a position of clinostatism;

2) The target area should be cleaned before treatment;

3) Closely touch the skin surface and press it appropriately;

4) The operation should be done in accordance with hair follicle’s growth direction;

5) Whether the anesthesia is needed or not is based on whether the treatment area is
sensitive;

6) Keep contact with patients while treating and pay attention to asking patients’
feeling and adjust reasonable parameters for treatment;

7) Patients with darken complexion and thick hair should be treated with low energy
density; while patients with light skin and thin hair should be treated with high
energy density;

8) Clean the treatment head with wet gauze timely and keep the treatment head
sanitized;

9) The Device must be turned off and keep it cool after the treatment is finished.

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9.4 Treatment Process

Make sure the emergency shut-off knob is released. Turn on the key switch, the water cooling and
screen begin to work and the system will be launched. After 5 seconds, a colorful screenwill be
shown. The system will enters the welcome interface.

9.4.1 Welcome Interface

Picture 1 Welcome Interface

The system will automatically transfer into start-up and self-test interface in 3 seconds.

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9.4.2 Self-test Interface

Picture 2 Start-up and Self-test interface

Self-tests include: status of hand piece connection, treatment hand piece temperature, diode driver,
water temperature, pump temperature, Diode Stack temperature, water flow, and hand piece
calibration parameters.

If the test is successful, this sign“ ”will be shown in follow grid, if not, “ ”will be shown.
If any of above tests is failed, the warning message box will pop out (warning display shown in
picture 8). Relevant failure code will be shown to remind the customer referring to the User Manual.
The system will be stopped until all the failure be solved. If all tests are passed, the device will
automatically switched to system operation interface.

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9.4.3Working Interface

Picture 3 Working interface

Fluence, Pulse width, Frequency, Skin Options and body parts in this interface can be adjusted
with relevant buttons.

9.4.3.1 Fluence

Fluence can be adjusted with buttons of and . Different skin options have different values.
2
The default value of Fluence is 8J/cm .

9.4.3.2 Pulse width

Pulse width can be adjusted with buttons of and .The pulse width could adjust from
5~400 ms, but it will be constraint by the fluence and frequency. Default value when Start-up is 40
ms.

9.4.3.3 Frequency

Frequency value can be adjusted by and for decreasing and increasing values. It could

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be adjust from 1 Hz to 10 Hz. The default value of Frequency is 4 Hz.

9.4.3.4 Skin Option and body parts

Skin options and body parts adjusting window could be displayed by pressing .

Picture 4 Skin type and treatment parts window

Skin types can be chosen based on real situations. There are 6 skin levels, “I, II, III, IV, V, VI”,
which can be chosen by pressing the number. The default level is “III”;

“Body Parts” are the treatment parts. There are 5 body parts, “Facial area, Oxter area, Bikini area,
Lower Limb, Upper Limb”, which can be chosen by pressing the picture. The default body parts is
“Facial Part”.

9.4.3.5 Standby and Ready

The switch button could be changed between Standby and Ready. The default state is

“Standby” . All parameters “standby” state can be adjusted with relevant buttons.
In the state of Standby, the device can’t emit light. Press “Ready”, the system will switch to ready

state . Then all adjustment buttons turn grey and can’t be adjusted in “ready”
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state. Light emitting could be realized according to the setting parameters.

9.4.3.6 Treatment Temperature

displays the sapphire window temperature that contact with the skin .
The default value is 5℃.

9.4.3.7 Counter

displays the counter of laser light emitting. Counter can be

cleared by pressing .

9.4.3.8 Treatment Parameters

Surgeons could adjust the technical parameters, such as “Fluence”, “Frequency” and “Pulse
Width” in accordance with different skin types and treatment areas. It is advisable that skin-test
shall be done before formal treatment so as to avoid discomfort or skin damage. For different skin
types and treatment areas, the system have defaulted the maximum Fluence for safety. The
following parameters, based on clinical practices for different skin types and treatment areas, can
be taken for reference:

Treatment Parameters Reference

Skin Types Body Parts Fluence(J/cm2) Frequency(Hz) Pulse Width(ms)

Facial Part 10 4 50

Oxter Part 10 4 70

I Bikini Area 9 5 80

Lower Limb 6 7 50

Upper Limb 6 7 50

Facial Part 9 4 50

Oxter Part 9 4 70

Bikini Area 8 5 80

II Lower Limb 6 7 50

Upper Limb 6 7 50

Facial Part 8 4 40

Oxter Part 11 3 70

III Bikini Area 8 4 90

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Lower Limb 7 5 70

Upper Limb 7 5 70

Facial Part 8 3 70

Oxter Part 9 3 70

Bikini Area 7 4 90

IV Lower Limb 6 5 70

Upper Limb 6 5 70

Facial Part 5 3 100

Oxter Part 8 3 80

Bikini Area 8 3 100

V Lower Limb 4 5 80

Upper Limb 5 5 80

Facial Part 3 3 100

Oxter Part 6 3 90

Bikini Area 5 3 100

VI Lower Limb 3 5 80

Upper Limb 3 5 80

Note: It is suggested that skin test shall be done before treatment based on parameters set in the
form, which can be personalized adjusted. (6 times for permanent hair removal, 4 times for
permanent hair reducing)

Customer can also readjust parameters based on patients’ skin reaction before treatment each
time and guarantee no damage will be caused to patient skin and achieve a best
treatment result.

Warning

Skin test is a must before treatment; the energy shall be increased from lower level; find
out the most appropriate energy and then carry out treatment with large areas.

9.4.4 Set-up Interface

Press the button on the top-right corner of working interface, the system will switch to set-up
interface.
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Picture 5 set-up interface

9.4.4.1 Equipment SN and Hand piece SN

Equipment SN and Hand piece SN show the equipment Serial Number and Hand piece Serial
Number.

9.4.4.2 Prompt tone

Laser emitting prompt tone button is provided, and the volume can be adjusted from 0-5. Press

for increasing volume to the maximum 5 while for decreasing volume to the minimum 0.

means no prompt tone while laser emitting. The default volume is 3.

9.4.4.3 Treatment Temperature Setting

The temperature of sapphire window can be adjusted with buttons

of and . It could be adjust from -4℃ to 10℃. The default is 5℃.

9.4.4.4 Language

Press in , the system will pop out language selection

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interface, which includes five languages: Chinese, English, German, Spanish and Russian. The
default language is English. As it is shown in picture 6, once a language is chosen, relevant grid will

show , click to hide the language selection message box.

Picture 6 Language selection interface

9.4.4.5 Product information

Press in , the system will pop out product information

interface, click for hiding the product information box. As Shown in picture 7.

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Picture 7 Product information interface

9.4.4.6 Modes of Laser Light Emitting

Three modes of laser emitting and two buttons are provided: hand piece and foot switch buttons.
Three modes of laser emitting are:

1) Laser emitting by pressing the button on Hand piece: Choose hand piece button and

relevant grid will become chosen , icon background will also turns green

from gray while non-selected foot switch will be , the system emits laser
only through pressing buttons on hand piece.

2) Laser emitting by operating the foot switch: Choose foot switch button and relevant grid

will become chosen , icon background will also turns green from gray while

non-selected hand piece button will be , the system emits laser only through
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stamping the foot switch.

3) Laser emitting by both pressing the button on hand piece and operating the foot switch
together: When both hand piece and foot switch are chosen, two grids will be lighted

up , and icon’s background will also turns green. Laser


emitting can only be realized by firstly stamping foot switch and then press button on
hand piece.

9.4.4.7 Total Counter

displays the total number of laser light emitting with the


hand piece.

9.4.4.8 Save setting

Press , the setting will be saved and the system will be switched to system working
interface.

Attention

If the energy is not appropriate after the system is launched, for readjusting energy,
customer needs to touch “Standby” and set relevant parameters.

Please press emergency shut off knob if any emergency happens;

Treatment skin with any damage or infection is not allowed;

Keep contacting with patients during treatment process; asking patients’ feelings and adjusting
treatment parameters.

Pay attention to the cooling down of surface skin. For those patients who are sensitive to pain,
having large skin areas for hair removal or larger energy needed, the treatment can be done
together with cold compress.

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9.4.5 Warning Alarm Interface

Picture 8 Warning Alarm Interface

If abnormities occur when system is in operation, the warning message will be popped out. The
surgeon could ignore the warning information by clicking the button ”OK”, Once the “OK” is
pressed, the system will be back to the screen before and can work normally. Wait the system back
to normal and continue to work. This interface provides warnings of overheated water tank,
overheated water pump, overheated diode stack, and interlock, which are shown in the following
form:

Warning code Implication

W01 overheated water tank

W03 overheated water pump

W04 overheated diode stack

W05 Interlock connecting error

Warning

According to application regulations of laser equipment, the remote control


interlock must be open if the laser device is in use, so as to avoid accidents. The interlock
shall be correctly installed. If W05 occurs after system is launched, it means the interlock is
unconnected. Please check relevant components.

If there is no way to use interlock because of force majeure, please contact with our

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professional engineers.

9.4.6 Error Interface

Picture 9 Error Interface

When error occurs, the system pops out relevant error indication number and will not be working.
Errors include oversize of output pulse width, Undersize of output pulse width, Oversize electric
current of constant current driver board, undersize electric current of constant current driver board,
undersize of water flow rate, hand piece linkage error, overheated treatment heads. If these errors
happen, please contact with manufacturer or agent for maintenance. Error codes are shown in the
following form:

Error Code Implication

E01 oversize of output pulse width

E02 Undersize of output pulse width

E03 Oversize electric current of constant current driver board

E04 undersize electric current of constant current driver board

E05 undersize of water flow rate

E06 hand piece linkage error

E07 overheated treatment heads

E08 Energy calibration parameter error

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E09 constant current driver board error

9.5 Equipment Turn Off

Click “Standby” and turn the key switch to “O”. Meanwhile, turn the power inlet switch to “O”.

10. Maintenance and Repair

10.1 Equipment Maintenance

The surface of the Device should be sanitized with alcohol wipes at least once a week. Neutral
detergent can be used but pay attention do not leak the liquid into the Device.

10.2 Clean of Treatment Head

Optical crystal should be cleaned all the time, and they must be cleaned after treatment every time.
As to the cleaning, firstly, soft cloth should be used to scrub and then use another piece of cloth
with anhydrous alcohol for cleanout and leave it naturally dry.

10.3 Equipment Repair

The following table lists some malfunctions and breakdowns that may happen to the Device and
corresponding measures:

phenomenon Possible causes Measures

Power unconnected Check power source

Emergency switch is Loosen the emergency switch and leave it in


No display
pressed the state of upspring

Other reasons Please contact with maintenance department

the system has no


Display screen
reactions when Please contact with maintenance department
malfunction or other
pressing buttons and do not disassemble it by yourself.
reasons
on the screen

Key is not turned on the


Swing the key clockwise to the right position
System won’t be right position
started Please contact with maintenance department
Other reasons
and do not disassemble it by yourself.

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Note: Please contact with us timely if you have any doubt during device using process.

10.4 Usable Life, Periodical Inspection and Disposal Requirements of

Equipment

The usable life of main console is 5 years. As the main applied part, the treatment hand piece has
a warranty period of 1 year since the date of contract signing. After using 1 year, the pulse energy
of hand piece will be decreased and need to be replaced.

In order to guarantee safety and effectiveness of treatment, this device shall be inspected and
standardized every 6 months.

Since equipment contains following materials and components, such as iron, copper, aluminum,
non-biodegradable plastics and printed circuit board, therefore at the end of device’s life, the above
materials and electric components must be recycled and processed at particular locations
designated by local environment department.

Addendum:

Version Description Date

A/0 Initial publication 2015-03-17

A/1 Update water flow detection warning and handling 2015-04-22

A/2 Update skin and treatment site selection interface 2015-05-22

A/3 Update water injection details 2015-06-18

A/4 Update Language UI picture, add 中文. 2015-11-02

A/5 Update the product and UI 2016-02-04

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